tetano
Editor, Senior Moderator
Int J Infect Dis. 2019 Dec 12. pii: S1201-9712(19)30483-7. doi: 10.1016/j.ijid.2019.12.010. [Epub ahead of print] [h=1]Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study.[/h]
Vesikari T[SUP]1[/SUP], Nauta J[SUP]2[/SUP], Lapini G[SUP]3[/SUP], Montomoli E[SUP]4[/SUP], van de Witte S[SUP]5[/SUP].
[h=3]Author information[/h] 1 Nordic Research Network Ltd, Biokatu 10, 33520 Tampere, Finland. 2 Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands. 3 VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy. 4 VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy; Department of Molecular and Developmental Medicine, University of Siena, 53100 Siena, Italy. 5 Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands. Electronic address: serge.vandewitte@abbott.com.
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] To analyze the immunogenicity and safety of inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV) in children and adolescents 3-17 years of age.
[h=4]METHODS:[/h] In this phase III, multicenter, double-blind study, 1200 subjects were randomized to receive QIV (n = 402), or TIV with the B-strain of the Victoria lineage (n = 404) or Yamagata lineage (n = 394). The primary objective was to demonstrate non-inferiority of QIV to TIV for immunogenicity against shared influenza strains, based on post-vaccination hemagglutinin inhibition (HI) titers. Secondary objectives were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains, and to further characterize immune response by analyzing virus neutralization and neuraminidase inhibition titers. Reactogenicity and safety were also compared post-vaccination.
[h=4]RESULTS:[/h] QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios [GMRs] of TIV/QIV < 1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV < 1.0; p < 0.0001) versus TIV. Reporting rates of local and systemic adverse reactions were similar between vaccine arms.
[h=4]CONCLUSIONS:[/h] QIV had comparable immunogenicity to TIV for shared strains and superior immunogenicity to the alternate-lineage B-strains in TIV. Safety and tolerability profiles were comparable.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Children; Immunogenicity; Neuraminidase inhibition; Quadrivalent influenza vaccine; Safety; Virus neutralization
PMID: 31838217 DOI: 10.1016/j.ijid.2019.12.010
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Vesikari T[SUP]1[/SUP], Nauta J[SUP]2[/SUP], Lapini G[SUP]3[/SUP], Montomoli E[SUP]4[/SUP], van de Witte S[SUP]5[/SUP].
[h=3]Author information[/h] 1 Nordic Research Network Ltd, Biokatu 10, 33520 Tampere, Finland. 2 Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands. 3 VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy. 4 VisMederi Srl, Strada del Petriccio e Belriguardo 35, 53100 Siena, Italy; Department of Molecular and Developmental Medicine, University of Siena, 53100 Siena, Italy. 5 Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, The Netherlands. Electronic address: serge.vandewitte@abbott.com.
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] To analyze the immunogenicity and safety of inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV) in children and adolescents 3-17 years of age.
[h=4]METHODS:[/h] In this phase III, multicenter, double-blind study, 1200 subjects were randomized to receive QIV (n = 402), or TIV with the B-strain of the Victoria lineage (n = 404) or Yamagata lineage (n = 394). The primary objective was to demonstrate non-inferiority of QIV to TIV for immunogenicity against shared influenza strains, based on post-vaccination hemagglutinin inhibition (HI) titers. Secondary objectives were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains, and to further characterize immune response by analyzing virus neutralization and neuraminidase inhibition titers. Reactogenicity and safety were also compared post-vaccination.
[h=4]RESULTS:[/h] QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios [GMRs] of TIV/QIV < 1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV < 1.0; p < 0.0001) versus TIV. Reporting rates of local and systemic adverse reactions were similar between vaccine arms.
[h=4]CONCLUSIONS:[/h] QIV had comparable immunogenicity to TIV for shared strains and superior immunogenicity to the alternate-lineage B-strains in TIV. Safety and tolerability profiles were comparable.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Children; Immunogenicity; Neuraminidase inhibition; Quadrivalent influenza vaccine; Safety; Virus neutralization
PMID: 31838217 DOI: 10.1016/j.ijid.2019.12.010
Free full text